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Sample Collection Registry for Quality Control of Biological and Environmental Specimens and Assay Development and Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087307
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : April 10, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

Study Description
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Brief Summary:

Background:

- Researchers are interested in developing a registry protocol to obtain biologic and environmental samples anonymously from adult volunteers for use in laboratory tests and studies. The samples will be used to determine if new tests are sufficiently valid and precise to be used in research studies and for quality control purposes.

Objectives:

- To provide a registry of samples for test development, validation, analysis, and quality control at the National Institute of Environmental Health Sciences.

Eligibility:

- Male and nonpregnant female volunteers at least 18 years of age.

Design:

  • Samples to be collected will include blood, urine, saliva, household dust, cheek cells, hair, nasal cells, stool, nail clippings, exhaled breath condensate, or sperm.
  • Specimens may be collected during a one-time sample collection, or participants may be asked to provide specimens on several occasions over a specified period, not to exceed 1 year.
  • Eligible participants will be asked to come to the clinical research unit to have their blood drawn and any noninvasive samples retrieved. Prior to blood draw, researchers will administer a brief past 24-hour questionnaire for research purposes. Specimens will be collected using standard clinical protocols.
  • Participants will receive monetary compensation for providing samples for this protocol.

Condition or disease
Exposure

Detailed Description:
We propose a sample collection registry protocol for use in obtaining biologic and environmental samples anonymously from adult volunteers for use in laboratory assay evaluation. The samples will be used to determine if new tests are sufficiently valid and precise to be used in research studies and for quality control purposes. In studies involving the storage and analysis of laboratory specimens, it is essential to evaluate the performance of available assays and to actively assess the impact of storage and handling on the quality of samples and laboratory analyses. Specifically, it is essential to 1) demonstrate that an assay is sufficiently reproducible and stable over time such that differences in levels among individuals in the population can be detected; 2) evaluate assay reliability by sending blinded anonymous samples along with study samples to testing labs for quality control purposes; 3) test proposed laboratories or methods by using replicate samples from the population in order to choose the laboratory or method with the greater precision, and; 4) assess how sample collection, handling, and storage procedures affect measured levels of specific analytes to allow for informed decisions about whether to proceed with a specific analysis. Under this protocol, assays could include evaluation of immunologic parameters, genes and gene products, peptides, proteins, hormones, lipids, viability of cells, evaporation and dilution effects, chemical toxins and their metabolites, micronutrients, metals and more. For some samples, lymphocytes will be extracted for use in studies of lymphocytes and/or immortalized cells. Samples to be collected will include blood, urine, saliva, household dust, cheek cells, hair, nasal cells, stool, nail clippings, exhaled breath condensate, sperm samples, skin cells, and/or sputum. In addition, a pulmonary function test (PFT) may be conducted to collect lung function information. Since it is important to collect samples from the general population, this protocol covers collection of samples from non-pregnant adults (male and female, age 18+). Specimens may be collected during a one-time sample collection, or participants may be asked to provide specimens on several occasions over a specified period, not to exceed one year.
Study Design
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Study Type : Observational
Actual Enrollment : 5326 participants
Observational Model: Other
Time Perspective: Other
Official Title: Sample Collection Registry for Quality Control of Biological and Environmental Specimens and Assay Development and Testing
Actual Study Start Date : March 2, 2010
Groups and Cohorts
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Group/Cohort
Healthy Adult Volunteer
Healthy adult volunteer


Outcome Measures
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Primary Outcome Measures :
  1. The endpoint is to create a biobank of samples which can be used for development and optimization of assays. [ Time Frame: 24 hours ]
    The objective of each collection is to generate a small pool of biological or environmental samples with which to develop and test specific laboratory assays, to maintain freezer and specimen handling quality control, to have blinded quality control specimens for testing labs, and to assess exposure variability over time.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy Volunteers
Criteria
  • ELIGIBILITY CRITERIA:

All participants must be non-pregnant and 18 years of age or older. No children, cognitively impaired persons, or prisoners will be enrolled.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087307


Locations
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United States, North Carolina
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Stavros Garantziotis, M.D. National Institute of Environmental Health Sciences (NIEHS)
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT01087307    
Other Study ID Numbers: 100063
10-E-0063
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: April 10, 2023
Last Verified: March 27, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: .There is no current plan to make IDP available to others.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ):
Serum
Urine Collection
Saliva
Natural History